Job Description

Title: CMC Document Specialist Reports to: Junior Manager R&D Quality Assurance and Technical Documentation The CMC Documentation Specialist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by supporting the documentation activities for regulatory submissions for pharmaceutical, veterinary and NHP products as part of Biolab\xe2\x80\x99s CMC Strategies. The CMC Regulatory Specialist has the responsibility to support new product approvals, existing product renewals, and post-approval changes for global registrations (Health Canada, ANVISA, FDA, others) in a timely manner while complying with departmental SOP\'s and guidelines set out by the regulatory agencies and ICH (International Conference on Harmonisation). This will be achieved by working very closely with the analytical development, formulation development and R&D QA teams. This role requires effective collaboration across technical functions to deliver on timelines for submissions. Key job responsibilities and duties:

• Responsible and accountable for the creation and assembly of module 2 and module 3 documents required to support the submission of new products as per departmental SOP\xe2\x80\x99s and ICH guidelines to Health Canada, FDA, ANVISA and other regulatory agencies. This should be done in consultation with RD&I Scientists, Managers and upper management.
• Assist with and support dossier creation and system compliance for regulatory submissions.
• Support the logistical process for regulatory submissions within Biolab sites.
• Collaborate with creation and assembly of regulatory documents, and team efforts to complete all relevant CMC documentation.
• Assist in the facilitation of authoring, review, verification, and submission-ready compliance for the finalization of filings.
• Participate in initiatives involved with regulatory filings.
• Participation in various cross-functional project teams, interactions with technical, scientific and regulatory staff at different Biolab sites and other key partners both internal and external to the company are necessary.

Education and experience requirements:

• Canadian equivalent to Bachelor of Science degree, preferably in Pharmacy, Chemistry or Pharmaceutical Chemistry. Advanced degree is an asset.
• More than three years of relevant hands on pharmaceutical experience in the creation and assembly of regulatory submission CMC documentation as per ICH, FDA and Health Canada guidelines.
• Demonstrated good understanding and proficiency in writing module 2 and module 3 documents following CTD and eCTD guidelines.
• Proven record of accomplishment for participating in the documentation activities for CMC regulatory filing.
• Demonstrated proficiency level in Microsoft word and Adobe Acrobat Pro DC
• Demonstrated ability to work independently or as a part of a team.
• Highly motivated and have the skills to handle multiple projects and prioritize the work.
• Excellent communication skills (oral and written) and interpersonal skills are required

Job Types: Full-time, Permanent Benefits:

• Casual dress
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Life insurance
• On-site parking
• Paid time off
• RRSP match
• Vision care

Flexible Language Requirement:

• French not required

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• No weekends

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Mississauga, ON: reliably commute or plan to relocate before starting work (required)

Education:

• Bachelor\'s Degree (required)

Experience:

• CMC hands-on: 3 years (required)

Work Location: One location